Amryt Pharma's Oleogel-S10 Application Gets FDA Priority Review Tag for Skin Blistering Disorder

The FDA has granted priority review status to Amryt Pharma's AMYT marketing application seeking approval for Oleogel-S10 to treat Epidermolysis Bullosa (EB).
Oleogel-S10 is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic EB, a rare genetic skin disorder characterized by blistering lesions on the skin and mucous membranes.
In general, the FDA's Priority Review designation accelerates the review time from ten months to a goal of six months from the date of acceptance of the filing.
The FDA has set a target action date of November 30.
Oleogel-S10 had previously received Fast Track Designation and Rare Pediatric Disease Designation from the FDA. If the NDA for Oleogel-S10 is approved, the company will apply for a priority review voucher.
"Confirmation of a target PDUFA date of November 30 keeps us on track for potential approval this year," said CEO Joe Wiley.
Yesterday, the FDA accepted for review the company's Oleogel-S10 marketing application. The agency had informed that notification of any filing review issues, including priority review determination and target action date, would be provided by June 12.
Related content: Benzinga's Full FDA Calendar.
Price Action: AMYT shares closed at $11.65 on Wednesday.